SERIES & GRADE:

POSITION INFORMATION:

PROMOTION POTENTIAL:

DUTY LOCATIONS:

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

SECURITY CLEARANCE:

Q - Nonsensitive

SUPERVISORY STATUS:

No

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

As a Consumer Safety Officer in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), you will provide guidance and consultation regarding inspection and investigation methods and procedures necessary to accomplish compliance/enforcement/regulatory objectives.

This announcement is open continuous till the closing date. Provided below are the following cut-off dates for certification:

June 21, 2014

July 21 2014

August 20, 2014

PHS Commissioned Corps Officers interested in
performing the duties of this position within the Commissioned Corps may
apply online to this announcement under the 003 occupational code.
Candidates will be referred to (CC) personnel and not as candidates for
conversion to a permanent career or career-conditional appointment.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-DE-1117949BB under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical locations.

QUALIFICATIONS REQUIRED:

To qualify applicants must meet the Basic Requirements (A or B) and the Additional Requirements listed below:

Basic Requirements:

A. Degree: that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming (MUST SUBMIT TRANSCRIPTS).

OR

B. Combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education (MUST SUBMIT TRANSCRIPTS).

Additional Requirements:

GS-11: Have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-09 level in the Federal service that included preparing and reviewing regulatory documents; assisting in interpreting legal and regulatory guidelines, including the Food, Drug and Cosmetic Act (FDCA) and Current Good Manufacturing Practices (cGMPs); and, researching and reporting on drug manufacturing and quality assurance activities; OR 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree (MUST SUBMIT TRANSCRIPTS); OR a combination of education and experience (MUST SUBMIT TRANSCRIPTS).

GS-12: Have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-11 level in the Federal service that included providing advice and interpretation of legal and regulatory guidelines to representatives or other project stakeholders of a regulated industry, including the Food, Drug and Cosmetic Act (FDCA) and Current Good Manufacturing Practices (cGMPs) as it relates to drug manufacturing and quality assurance activities; and negotiating the acceptance of practices and actions to resolve regulatory compliance issues with drug manufacturing and quality assurance policies and practices.

GS-13: Have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-12 level in the Federal service that included coordinating quality assurance activities of a drug manufacturer; developing new policies, approaches, or methods to improve drug manufacturing and quality assurance activities of an organization; consulting senior management officials of a regulated industry on legal and regulatory guidelines, including the Food, Drug and Cosmetic Act (FDCA) and Current Good Manufacturing Practices (cGMPs); and negotiating the acceptance of practices and actions to resolve regulatory compliance issues with drug manufacturing and quality assurance policies and practices.

Time-in-Grade Requirements: Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under a non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). Time-In-Grade requirements also apply to current employees applying for a Veterans Employment Opportunities Act of 1998 (VEOA) appointment. NOTE: You must provide a copy of a recent SF-50, "Notice of Personnel Action" that indicates proof of status and time-in-grade eligibility. The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).

This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.

All qualification requirements must be met by11:59 PM (Eastern Time) on the closing date of this vacancy announcement. Failure to provide any of the above will result in an ineligible rating.

Conditions of Employment:

1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

4. Financial disclosure statement may be required.

5. Travel, transportation, and relocation expenses will be paid: No

6. Bargaining Unit Position: Yes

7. Drug Screening Required: No

8. Recruitment incentives may be authorized: No

9. Student loan repayment incentive authorized: No

10. Annual leave for non-federal service authorized: No

HOW YOU WILL BE EVALUATED:

Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Eligibles: The highest rated candidates will be referred to the hiring agency.

For Noncompetitive Appointment Eligibles: All qualified candidates will be referred to the hiring agency.

The assessment questionnaire is designed to measure the following competencies that are required for this position:

BENEFITS:

OTHER INFORMATION:

Veterans Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).

Career Transition Program: This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated 'well-qualified. Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and what documents to submit as a CTAP/ICTAP eligible, go to:www.opm.gov/rif/employee_guides/career_transition.asp.

Noncompetitive Appointment Authorities: The following links contain information on the eligibility requirements to be considered under a noncompetitive appointing authority:

Selective Service: The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position. For further information concerning Selective Service requirements, please visit http://www.sss.gov/.

* It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.

To verify your application is complete, log into your USAJOBS account @ https://my.usajobs.gov/Account/Loginand click the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

To return to an incomplete application, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.

To complete a hard copy assessment questionnaire and submit it via fax:Do not complete the steps below if you have already applied online to the questionnaire for this position.

2) Print the 1203FX form to record your responses to the questionnaire.

3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to: 1-478-757-3144

REQUIRED DOCUMENTS:

Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.

Responses to the Assessment Questionnaire

Standard Form 50 (if you are a current or former Federal service employee) The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).

College transcripts (if qualifying all or in part based on your education)

2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Wednesday, August 20, 2014 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

APPLICATION MATERIALS MUST BE RECEIVED BY 11:59PM (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT